EP0793458A1 - A self-expanding endovascular stent assembly, a method for the manufacture thereof and a stent introducer set comprising such a stent assembly and an introducer catheter for introduction of said stent into a body passage or duct of a patient - Google Patents
A self-expanding endovascular stent assembly, a method for the manufacture thereof and a stent introducer set comprising such a stent assembly and an introducer catheter for introduction of said stent into a body passage or duct of a patientInfo
- Publication number
- EP0793458A1 EP0793458A1 EP96928365A EP96928365A EP0793458A1 EP 0793458 A1 EP0793458 A1 EP 0793458A1 EP 96928365 A EP96928365 A EP 96928365A EP 96928365 A EP96928365 A EP 96928365A EP 0793458 A1 EP0793458 A1 EP 0793458A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- stent
- radius
- self
- stent assembly
- sleeve
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
Definitions
- a self-expanding endovascular stent assembly, a method for the manufacture thereof and a stent introducer set comprising such a stent assembly and an introducer catheter for introduction of said stent into a body passage or duct of a patient.
- the invention relates to a self-expanding endova ⁇ scular stent assembly
- a self-expanding endova ⁇ scular stent assembly comprising at least one stent segment with a metal wire body formed by a single piece of wire arranged in a closed zig-zag configuration including an endless series of struts joining each other in an equal number of joints and a covering sleeve made of a bio-compatible plastic film material, said stent segment being compressible from an expanded condition of a mainly cylindrical shape having a first radius into an introduction condition in which it assumes a smaller second radius.
- Endovascular stents of this type is generally used in preventing restenosis or closure by tumors of passageways and ducts in the body of a patient and for percutaneous repair of aneurysms.
- a stent assembly of this kind is known in which the metal wire bodies of one or more stent segments are surrounded by a flexible, elastic sleeve, e.g. of nylon, covering the gaps between the struts of the metal wire bodies.
- the joints between the struts at either end of each segment are shaped into eyes by bending the wire to form a cusp and, then, welding or soldering the wire back upon itself .
- the stent segments are firmly attached to the flexible sleeve either by stitching or glueing or embedding the segments in the sleeve when the latter is made of a plastic material.
- the stent segments are connected with each other by tieing the eyes formed at the joints of two segments with thread.
- this prior art device is capable of percutaneous implantation, e.g. in the bilary duct and, due to the covering flexible sleeve, is effective for permanent prevention of in-growth of a tumor between the struts of the segment, it suffers from various practical disadvantages.
- the manufacture is relative ⁇ ly complicated due to the welding or soldering operation required for forming the eyes at the joints of the struts and the mutual connection of stent segments by tieing the eyes of two stent segments positioned end to end with thread. Since proper implantation requires the stent assembly to be able to resist contraction along the axis, application of the sleeve material to the stent segments must take place in the compressed condition of the latter.
- the thread used for tieing the eyes of two segments together will add to the minimum thickness of the stent in the compressed condition which sets a lower limit to the internal diameter of the catheter used for percutaneous introduction.
- a self-expanding stent assembly of the kind defined is characterized in that the struts of said metal wire body are retained solely by said sleeve, said sleeve being relatively unelastic and having a thickness of not more than 1 % of said first radius.
- the invention also relates to a method of manufac ⁇ turing a self-expanding stent assembly of the kind set forth, which is characterised in that at least one stent segment is made by forming a metal wire body from a single piece of wire arranged in a closed zig-zag configuration with a series of struts and joints to form a mainly cylindrical shape having said first radius, a plastic film covering being applied to said metal wire body in a thickness not exceeding 1 % of said first radius in such a way as to connect said film material with the wire material of said metal wire body in said joints .
- the invention also relates to a stent introducer set comprising the self-expanding stent assembly as defined herein before and an introducer cathether for introduction of said stent assembly into a passageway or duct of a patient .
- a stent introducer set comprising the self-expanding stent assembly as defined herein before and an introducer cathether for introduction of said stent assembly into a passageway or duct of a patient .
- such an introducer set is characterized in that the introducer catheter has an internal radius not exceeding 25 % of said first radius.
- FIG. 3 is a cross-sectional representation of the stent assembly in fig. 2; fig. 4 is a side representation of the stent assembly in figs. 2 and 3 in a partly compressed condition; and figs. 5 and 6 are schematical illustrations of the dimensional features of the stent assembly according to the invention.
- Fig. 1 shows two segments 1 and 2 of the prior art stent known from EP-A-0 480667 surrounded by a flexible elastic sleeve 3 which may be of nylon and to which segments 1 and 2 are firmly attached by stitching or gluing or being embedded in sleeve 3.
- Each of segments 1 and 2 is formed from a metal wire body formed from a single piece of wire arranged in a closed zig-zag configuration with an endless series of struts 4 joining each other in joints 5 shaped into eyes which are tied with thread 6 to connect segments 1 and 2 with each other.
- sleeve 9 is made of a relatively inelastic material such as high-density polyethylene and has a small thickness of not more than 1 per cent of the radius R of the stent in the expanded condition as also shown in fig. 3, said thickness being preferably not greater than 30 ⁇ , but preferably at least 20 ⁇ .
- sleeve 9 may in order to retain the metal wire bodies of segments 7 and 8 be composed of two layer of film 9a and 9b each having a thickness of e.g. 12 ⁇ .
- L is the length of each of struts 10 and 8 and is the angle included between two successive struts 10 of the metal wire body of each segment 7 or 8.
- x represents the axial length of each segment 7 or 8 in the expanded state, and x + d repre ⁇ sents the avial length of each segment 7 or 8 in the compressed state of introduction.
- segments 7 and 8 are not firmly attached to sleeve 9 and are not tied together by an additional thread as in the prior art stent of figs. 1 - 4, the external radius r in the introduction state may be minimized.
- each of segments 7 and 8 is made up of 13 struts joining each other in 7 joints and further that the wire thickness of each strut is 0.25 mm
- the radius of curvature of each joint is 0.32 mm
- an introducer catheter of a minimum internal radius of 1,25 mm such as a 7 French catheter having an internal diameter of 2.33 mm and an internal cross sectional area of 4.276 mm 2 .
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/529,474 US5562697A (en) | 1995-09-18 | 1995-09-18 | Self-expanding stent assembly and methods for the manufacture thereof |
US529474 | 1995-09-18 | ||
PCT/DK1996/000378 WO1997010777A1 (en) | 1995-09-18 | 1996-09-10 | A self-expanding endovascular stent assembly, a method for the manufacture thereof and a stent introducer set comprising such a stent assembly and an introducer catheter for introduction of said stent into a body passage or duct of a patient |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0793458A1 true EP0793458A1 (en) | 1997-09-10 |
EP0793458B1 EP0793458B1 (en) | 2003-11-12 |
Family
ID=24110066
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP96928365A Expired - Lifetime EP0793458B1 (en) | 1995-09-18 | 1996-09-10 | A self-expanding endovascular stent assembly, a method for the manufacture thereof and a stent introducer set comprising such a stent assembly and an introducer catheter for introduction of said stent into a body passage or duct of a patient |
Country Status (8)
Country | Link |
---|---|
US (1) | US5562697A (en) |
EP (1) | EP0793458B1 (en) |
AT (1) | ATE253877T1 (en) |
AU (1) | AU6786496A (en) |
DE (1) | DE69630668T2 (en) |
DK (1) | DK0793458T3 (en) |
ES (1) | ES2211968T3 (en) |
WO (1) | WO1997010777A1 (en) |
Families Citing this family (115)
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US4580568A (en) * | 1984-10-01 | 1986-04-08 | Cook, Incorporated | Percutaneous endovascular stent and method for insertion thereof |
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US5123917A (en) * | 1990-04-27 | 1992-06-23 | Lee Peter Y | Expandable intraluminal vascular graft |
ES2085435T3 (en) * | 1990-10-09 | 1996-06-01 | Cook Inc | PERCUTANEOUS DILATOR DEVICE. |
JPH0717314Y2 (en) * | 1990-10-18 | 1995-04-26 | ソン ホーヨン | Self-expanding intravascular stent |
US5403341A (en) * | 1994-01-24 | 1995-04-04 | Solar; Ronald J. | Parallel flow endovascular stent and deployment apparatus therefore |
-
1995
- 1995-09-18 US US08/529,474 patent/US5562697A/en not_active Expired - Lifetime
-
1996
- 1996-09-10 EP EP96928365A patent/EP0793458B1/en not_active Expired - Lifetime
- 1996-09-10 ES ES96928365T patent/ES2211968T3/en not_active Expired - Lifetime
- 1996-09-10 DE DE69630668T patent/DE69630668T2/en not_active Expired - Lifetime
- 1996-09-10 AT AT96928365T patent/ATE253877T1/en not_active IP Right Cessation
- 1996-09-10 WO PCT/DK1996/000378 patent/WO1997010777A1/en active IP Right Grant
- 1996-09-10 DK DK96928365T patent/DK0793458T3/en active
- 1996-09-10 AU AU67864/96A patent/AU6786496A/en not_active Abandoned
Non-Patent Citations (1)
Title |
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See references of WO9710777A1 * |
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WO1997010777A1 (en) | 1997-03-27 |
DK0793458T3 (en) | 2004-03-15 |
DE69630668D1 (en) | 2003-12-18 |
ATE253877T1 (en) | 2003-11-15 |
AU6786496A (en) | 1997-04-09 |
US5562697A (en) | 1996-10-08 |
ES2211968T3 (en) | 2004-07-16 |
EP0793458B1 (en) | 2003-11-12 |
DE69630668T2 (en) | 2004-09-30 |
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